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Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19

Primary Purpose

Covid19, Critical Illness, Critical Illness Polyneuromyopathy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Robotic assisted early mobilization
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID19, Early mobilization, robotics, Vemo

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Invasive mechanically ventilated and expected to be ventilated for another 24 hours
  • Cardiovascular stability, allowing mobilization
  • Respiratory stability, allowing mobilization

Exclusion Criteria:

  • Bed-bound before ICU admission
  • Bed-rest order or contraindication of weight load of the lower extremity or spine
  • Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
  • Fresh SAB, ICB or elevated ICP
  • Status epilepticus
  • Acute intoxication
  • Shock with catecholamine doses >0.3μg/kg/min or acute bleeding including organ ruptures
  • Multiorgan failure with lactate > 4 mmol/l
  • Body height outside the range 150-195 cm
  • Body weight outside the range 45-135 kg
  • pAVK IV°
  • Pacemakers or other electrical stimulators
  • Implanted medical pumps
  • Pregnancy
  • Life expectancy below 7 days or acute palliative care situation
  • Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request
  • Unable to understand the official language

Sites / Locations

  • Charité - Univiversitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Robotic assisted early mobilization

Standard Care

Arm Description

Early mobilization therapy assisted with robotics

Mobilization according to standard care by staff

Outcomes

Primary Outcome Measures

Level of mobilization
Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10)
Level of mobilization
Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4)

Secondary Outcome Measures

Frequency of Mobilization
Frequency of early mobilization during mechanical ventilation
Initiation of first Mobilization
Time of first mobilization after admission on ICU (in hours)
Mobilization duration
Average duration of mobilization sessions during mechanical ventilation (in min)
Depth of sedation
Depth of sedation measured with RASS during the first 5 days after admission on ICU
Days of sedation
Days under sedative medication during ICU stay
Days of mechanical ventilation
Days of mechanical ventilation during ICU stay
Days of Intubation
Days of Intubation during ICU stay
Days of Delirium
Days of Delirium during ICU stay
MRC Score
MRC Score at ICU Discharge
Muscle wasting
Muscle wasting assessed using ultrasound measurement of the M. femoris
Number of Health care provider
Number of Health care provider needed for mobilization
Mortality
Mortality during ICU and Hospital stay and 180 days after admission at ICU
Length of stay
Length of stay at ICU , in Hospital (in days)
Global function
Global function measured with WHODAS
Health care provider assessment
Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)
Safety events
Frequency of safety events during mobilization
Functional status
Measurement of ADLs/IADLs for which patients need assistance
DRG workplace data
expenses of the hospital stay

Full Information

First Posted
February 9, 2021
Last Updated
August 9, 2023
Sponsor
Charite University, Berlin, Germany
Collaborators
Reactive Robotics GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04750265
Brief Title
Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19
Official Title
Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19: an Interventional Randomized, Controlled Feasibility Study (ROBEM II Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
August 8, 2021 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Reactive Robotics GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Critical Illness, Critical Illness Polyneuromyopathy, Early Mobilization, Rehabilitation, Robotics
Keywords
COVID19, Early mobilization, robotics, Vemo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, parallel-group, open label pilot trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic assisted early mobilization
Arm Type
Experimental
Arm Description
Early mobilization therapy assisted with robotics
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Mobilization according to standard care by staff
Intervention Type
Device
Intervention Name(s)
Robotic assisted early mobilization
Intervention Description
Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.
Primary Outcome Measure Information:
Title
Level of mobilization
Description
Level of mobilization during the first 5 days after admission on the ICU, measured with the ICU-Mobility Scale (0-10)
Time Frame
5 days
Title
Level of mobilization
Description
Level of mobilization during the first 5 days after admission on the ICU, measured with the Surgical Optimal Mobilization Scale (0-4)
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Frequency of Mobilization
Description
Frequency of early mobilization during mechanical ventilation
Time Frame
5 days
Title
Initiation of first Mobilization
Description
Time of first mobilization after admission on ICU (in hours)
Time Frame
5 days
Title
Mobilization duration
Description
Average duration of mobilization sessions during mechanical ventilation (in min)
Time Frame
5 days
Title
Depth of sedation
Description
Depth of sedation measured with RASS during the first 5 days after admission on ICU
Time Frame
5 days
Title
Days of sedation
Description
Days under sedative medication during ICU stay
Time Frame
during ICU stay (normally up to 30 days)
Title
Days of mechanical ventilation
Description
Days of mechanical ventilation during ICU stay
Time Frame
during ICU stay (normally up to 30 days)
Title
Days of Intubation
Description
Days of Intubation during ICU stay
Time Frame
during ICU stay (normally up to 30 days)
Title
Days of Delirium
Description
Days of Delirium during ICU stay
Time Frame
during ICU stay (normally up to 30 days)
Title
MRC Score
Description
MRC Score at ICU Discharge
Time Frame
One time point before ICU Discharge
Title
Muscle wasting
Description
Muscle wasting assessed using ultrasound measurement of the M. femoris
Time Frame
5 days
Title
Number of Health care provider
Description
Number of Health care provider needed for mobilization
Time Frame
5 days
Title
Mortality
Description
Mortality during ICU and Hospital stay and 180 days after admission at ICU
Time Frame
at 180 days after study start
Title
Length of stay
Description
Length of stay at ICU , in Hospital (in days)
Time Frame
Hospital stay (approx. 30 days)
Title
Global function
Description
Global function measured with WHODAS
Time Frame
at 180 days after study start
Title
Health care provider assessment
Description
Assessment of the satisfaction with the mobilization by the health care provider using Likert-Scales (1-5)
Time Frame
5 days
Title
Safety events
Description
Frequency of safety events during mobilization
Time Frame
5 days after study start
Title
Functional status
Description
Measurement of ADLs/IADLs for which patients need assistance
Time Frame
at 180 days after study start
Title
DRG workplace data
Description
expenses of the hospital stay
Time Frame
Hospital stay (approx. 30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Invasive mechanically ventilated and expected to be ventilated for another 24 hours Cardiovascular stability, allowing mobilization Respiratory stability, allowing mobilization Exclusion Criteria: Bed-bound before ICU admission Bed-rest order or contraindication of weight load of the lower extremity or spine Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis Fresh SAB, ICB or elevated ICP Status epilepticus Acute intoxication Shock with catecholamine doses >0.3μg/kg/min or acute bleeding including organ ruptures Multiorgan failure with lactate > 4 mmol/l Body height outside the range 150-195 cm Body weight outside the range 45-135 kg pAVK IV° Pacemakers or other electrical stimulators Implanted medical pumps Pregnancy Life expectancy below 7 days or acute palliative care situation Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request Unable to understand the official language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan J Schaller, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Univiversitätsmedizin Berlin
City
Berlin-Mitte
State/Province
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Depersonalized data can be requested from the PI after publication of the study for scientific purpose.
IPD Sharing Time Frame
After publishing results.
IPD Sharing Access Criteria
Data will be shared to other researchers on reasonable request.

Learn more about this trial

Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19

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